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Friday, July 27, 2018

Seasteading and Health Care: Islands of Innovation

Innovation in health care is woefully lacking and government red tape is largely to blame, but seasteading just might be a way to circumvent bureaucracy without sacrificing quality.

Mention seasteading at a party, and you will likely get the same glassy-eyed stares that the topic of Bitcoin garnered five years ago. Of course, by now most of us understand the revolutionary implications of cryptocurrencies and blockchain technology. But the significance of seasteading is, unfortunately, still lost on some.

For anyone reading this with glassy eyes of their own, seasteading “is the concept of creating permanent dwellings at sea, called seasteads, outside the territory claimed by any government.” And while seasteading offers hope for a future where individual sovereignty is protected and out of reach of government abuse, it also provides ample opportunity to reinvent the way we view health care innovation.

Regulatory Burdens Inhibit Innovation

As developed and prosperous as America is, its health care system is severely lacking. And while supporters of government intervention will tell you this is because the private sector has too much power and influence over our care options, this is simply not the case. In fact, much of the reason that our health care system is both inefficient and overpriced is because it is one of the most heavily regulated sectors.

The truth of the matter is that the regulatory burdens placed on the health care sector harm those who are in most need of care.

The approval process for new drugs, treatments, and medical devices is both pricey and rigorous. This makes it exceedingly difficult for any new progress to be made quickly. In addition to the 1,000 pages of paperwork that must be completed during the application process, it can take up to two and a half years for the government to grant approval. And this is assuming that the entire process runs smoothly which, given the nature of government bureaucracies, is not always the case. Not to mention, prior to 2012, all applications for new treatments had to be submitted through the mail, only adding to its length. It was not until recently that the FDA updated its process to allow online submissions, symbolizing just how outdated the government truly is.

As far as costs are concerned, the Tufts Center for the Study of Drug Development projected that the approval process costs a whopping $2.9 billion. This presents a huge financial strain for smaller companies that are not as well funded as larger pharmaceutical brands.

And while governments often defend this process by saying that they are responsible for protecting health care consumers against fraudulent or potentially dangerous treatments, the truth of the matter is that the regulatory burdens placed on the health care sector harm those who are in most need of care.

Accessibility of Care

And in the absence of FDA approval, patients suffering from life-threatening illnesses are forbidden from even experimenting with potentially life-saving treatments, lest they be viewed as criminals. “Right to try” laws seem to be gaining more popularity as of late, which is a good signal that many are starting to see the absurdity in telling terminally ill patients that they cannot take every step possible to ensure their survival.

The use of medical tourism has surged over the last decade.

But those facing the prospect of dying, and those living with chronic conditions, do not have the luxury of waiting on the laws to change or for the FDA approval processes to be completed. And this is where foreign governments have had an advantage. The use of medical tourism has surged over the last decade, as many North American and European health care consumers have chosen to go abroad in search of more affordable and higher quality care than is offered in their own countries.

India, for example, has become a beacon of state-of-the-art heart surgery. In America, heart surgeons are limited in the number of operations that can be performed each day. But free from the regulatory burdens that have prevented American physicians from being able to meet the demand of those needing heart surgery, Dr. Devi Shetty and his team of expert heart surgeons are able to perform around 300 surgeries a day. This is in contrast to the 32 surgeries per day performed in most American facilities.

Dr. Shetty’s famous Narayana Hrudayalaya Heart Hospital has also managed to dramatically slash surgical costs while offering higher quality care than we experience in America. This has resulted in many foreign patients traveling to India for cardiac care. Even when the cost of travel and lodging are factored in, these patients still save money traveling to India for heart surgery.

Seasteading offers the possibility of setting up floating man-made islands almost anywhere in the ocean, drastically expanding the accessibility of care.

But what if patients didn’t have to travel so far to receive this level of care at an affordable cost? It was precisely this inquiry that led Dr. Shetty to open a medical facility on the Cayman Islands. Health City offers patients living in neighboring countries, and all over the world, a place to more easily travel to receive affordable, high-quality care.

While islands provide a more accessible solution than, say, traveling to India, the possibilities are still limited to existing islands. But seasteading, on the other hand, offers the possibility of setting up floating man-made islands almost anywhere in the ocean, drastically expanding the accessibility of care. And therein lies the beauty and potential for seasteading to disrupt the stagnation of not just the American health care system.

The Seasteading Solution

Currently, 45 percent of the earth is free from any government jurisdiction. And it is precisely this lack of governance that makes medical innovation possible. Since the sea is unclaimed territory, creating medical facilities, whether on ships or floating islands, allows medical innovators to bypass the regulatory processes that are keeping patients from receiving the care they need.

Two seasteading medical pioneers, Allison and Chris Heddon, are on a mission to show the world how seasteading can create a more innovative future for health care.  

In Joe Quirk’s book Seasteading: How Floating Nations Will Restore the Environment, Enrich the Poor, Cure the Sick, and Liberate Humanity from Politicians, Allison, who is the vice president of Resonance Medical, which is described as a “software company that helps translate the sensory world into electrical signals that the brain can better understand” speaks of the importance of health care seasteads:

By taking our medical research offshore and partnering with the right individuals, we have a unique opportunity to efficiently and safely reshape the regulatory pathway… Through collaboration, we can set an example of how medical research can be conducted in the hopefully not-so-distant future. I believe that seasteading is the first step in a new regulatory paradigm that ensures patients have access to life-saving treatments without having to wait years for the drug or medical device to travel through the US regulatory pathway. In no way does this mean that testing and assessment on a seastead would be lax or haphazard. Rather, it is easier for a smaller organization to move quickly and with agility than a larger, government-run department.

Allison Heddon’s husband, Dr. Chris Heddon, who is the Founding CEO of Resonance Medical and an attending anesthesiologist, echoed her sentiments and spoke of the regulatory burdens placed on the medical sector saying:

If you’re in an industry like medicine, where I spent most of my professional life, you see that we have a bag of bricks attached to our legs. And that’s all regulation. I think it’s become obvious that one segment of business, namely Silicon Valley, is taking off, because they’re so much more efficient, and we’re left behind. There’s a disparity between the speed at which information technology is improving, the speed at which medical technology is improving, and it’s holding humanity back.

He continued:

I think it’s important that we speed that process up and show people that there’s a better way. Seasteading is a way to illuminate that disparity, to become the lighthouse on the hill that everybody looks to for innovative medicine and other highly regulated industries. It’s very important. I think it’s a moral imperative.

While all this sounds great, there are still many who worry about medical research conducted without the oversight of a regulatory agency like the FDA. But just because medical research conducted on seasteads wouldn’t be subjected to the same laws doesn’t mean that quality would suffer. On the contrary, Allison said, “If the team is not unquestionably better than what the government has put together in the FDA, then it’s not worth undertaking.” She later added, “Obviously, safety and efficacy would be top priorities on a seastead research facility, just like the land-based IRBs [institutional review boards]…”

Backing up his wife’s statements, Chris added:

Only excellence and a proven safety record over time merit trust. The first people who choose to be treated are going to be pioneers, and it’s going to be up to them to do their own research on the team behind the seastead’s research. If the team is top notch and has excellent backing, that’s a good sign, but those criteria go for almost anything. I think that seasteads will have a higher burden of proof than a typical research institution, so it will be important to be extraordinarily open and welcoming to interested regulatory bodies. If you want to set yourselves up as a model for how things should be, you subject yourselves to scrutiny willingly.

In addition to a commitment to quality and excellence, Allison does not view the work she and Chris are doing as being at odds with the FDA and the federal government. Instead, she views their work as complementary to the that of the government:

Our proposed use of seasteading for medical research will be designed to supplement the FDA and shift some of the regulatory burden away from their overworked team and to a more agile regulatory option. If properly organized and with careful design, seasteading has the potential to alleviate some of the stress on regulatory agencies by taking on medical research. Today promising drugs and medical devices take years to get to the market. Unfortunately, this lengthy and slow process often keeps potentially life-saving treatments out of the hands of patients who could benefit greatly from them.

A Healthy Future

Our health care system is overburdened by regulation, and health care consumers ultimately pay the cost. But perhaps, if the government begins to recognize that American consumers are traveling abroad for care in order to escape the red tape and high price tag of the U.S. health care system, they will be encouraged to deregulate in order to compete. Either way, it is clear that the solution to fixing our broken health care system will not come from Washington.

But health care pioneers like the Heddons and Dr. Shetty are proving that medical care is not something that needs to be controlled by the state in order to benefit patients. But rather, real reform will come from the freedom to innovate and bring health care into the modern era. And seasteading provides the opportunity for a healthy future, where patients are in control of their care and free from government restraint.

  • Brittany is a writer for the Pacific Legal Foundation. She is a co-host of “The Way The World Works,” a Tuttle Twins podcast for families.